Emergent BioSolutions, Inc. is one of two 2108 Facility of the Year Honorable Mention winners for their BARDA– Emergent Center for Innovation in Advanced Development and Manufacturing (CIADM) Baltimore Facility Expansion project in Baltimore, MD, USA.
Projects selected for recognition with an Honorable Mention Award are typically projects that utilize new technology or located in a challenging region of the world. These projects do not win for a specific category but are clearly successful projects that overcame significant challenges in planning, execution, and delivery and deserve recognition for their achievements.
Rising terror threats leveraging biological weapons like anthrax and global health events like the H1N1 and SARS outbreaks pose a considerable and ever-increasing risk to US citizens. The Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response in the US Department of Health and Human Services exists for the sole purpose of providing integrated, systemic approaches to the development and purchase of the necessary vaccines, drugs, therapies and diagnostic tools for public health medical emergencies
As a primary supplier of the anthrax vaccine, Emergent BioSolutions has been at the forefront of the US’ efforts to defend Americans for almost 15 years and was a deciding factor that led to Emergent’s selection as a BARDA partner and the establishment of a Center for Innovation in Advanced Development and Manufacturing (CIADM).
Emergent’s CIADM facility is one of only three facilities in the US developed with the primary purpose of providing rapidly deployed development and manufacturing capabilities in response to a global influenza pandemic. Emergent’s base contract requires the ability to manufacture, test and release 50 million doses of novel pandemic flu vaccine in its final dosage form within four months of pandemic declaration and the ability to produce a total of 100 million doses within six months of declaration.
Emergent was tasked to deliver a facility that is capable of surge production of vaccines manufactured through novel processes in response to pandemic flu events and that can support production of other medical countermeasures for BARDA task orders. Emergent’s own business objectives demanded that the facility be nimble enough to produce other internal product candidates in addition to the novel vaccine processes still in development. The combination of BARDA’s requirements for rapid production of novel vaccines with Emergent’s own shifting internal pipeline took the complex challenge of flexible facility design to an entirely new level, thus creating the next evolution of the facility of the future.
ISPE congratulates the Emergent BioSolutions team for their achievements and their FOYA award-winning entry. Learn more about the 2018 FOYA Honorable Mention winner.
To meet the biopharmaceutical industry’s duty to manufacture safe and effective therapies for patients, a robust quality system is fundamental to success. A quality system should link to quality culture and prioritize focusing on quality, led by management, that fosters sustainable compliance and consistent production of high-quality drugs. Strong quality culture attributes include a proactive...
Stability sampling and testing are key to ensuring that products maintain safety, identity, strength, purity, and quality throughout their claimed shelf life. It is also a regulatory requirement per ICH Q5. However, storing product samples in different environmental conditions, testing those samples for three to five years (or more) after initial manufacture, and properly analyzing and...
ISPE hosted more than 450 attendees in person and virtually for the 2024 ISPE Aseptic Conference in Vienna, Austria. Keynotes and education sessions provided a comprehensive overview of key topics and trends...